A Study of Once-Daily NNC0090-2746 in Participants With Type 2 Diabetes Inadequately Controlled With Metformin

Part of paid clinical trials in Chino, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT02205528
Phase
PHASE2
Status
Completed

Conditions

  • Diabetes
  • Diabetes Mellitus Type 2

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — DRUG
    Liraglutide will be self-administered daily via SC injection according to manufacturer specifications.
  • Metformin — DRUG
    Metformin hydrochloride immediate- or extended-release oral tablets will be supplied by the participant or investigational site as standard-of-care treatment beginning at least 8 weeks prior to randomization and throughout the 12-week treatment period. Metformin will also be continued during the 4-week follow-up. Dose selection will be based upon manufacturer specifications.
  • Placebo — DRUG
    Matching placebo to NNC0090-2746 will be self-administered daily via SC injection.
  • NNC0090-2746 — DRUG
    NNC0090-2746 solution will be self-administered in daily doses of 1.8 mg via SC injection.

Study Details

This trial is conducted in the United States of America (USA). The aim of the trial is to investigate the efficacy, safety, and tolerability of once-daily subcutaneous (SC) injections of NNC0090-2746 for 12 weeks, as an adjunct to metformin, in participants with T2D.

Key Dates

Start date
Aug 18, 2014
Status verified
Jul 2020
Primary completion
Sep 15, 2015
Completion
Sep 15, 2015

Study Design

Enrollment
108 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Treatment Period: Placebo QD
    Participants will receive daily SC placebo injections during the 12-week, double-blind treatment period.
  • Experimental: Treatment Period: NNC0090-2746 QD
    Participants will receive daily 1.8-mg SC injections of NNC0090-2746 during the 12-week, double-blind treatment period.
  • Active Comparator: Treatment Period: Liraglutide QD
    Participants will receive open-label liraglutide via SC injection during the 12-week treatment period. The dose scheme will be as follows: 0.6 milligrams (mg) each day during Week 1, followed by 1.2 mg each day during Week 2, and 1.8 mg each day from Weeks 3 to 12.

Primary Outcome Measure

Change in HbA1c [ Time Frame: Day 1; Week 8 ]

Locations (20)

FacilityCityStateZIPSite coordinators
Novo Nordisk Investigational SiteChinoCalifornia91710-
Novo Nordisk Investigational SiteHawaiian GardensCalifornia90716-
Novo Nordisk Investigational SiteLos AngelesCalifornia90057-
Novo Nordisk Investigational SiteSpring ValleyCalifornia91978-
Novo Nordisk Investigational SiteHialeahFlorida33012-
Novo Nordisk Investigational SitePort OrangeFlorida32127-
Novo Nordisk Investigational SiteSanfordFlorida32771-
Novo Nordisk Investigational SiteChicagoIllinois60607-
Novo Nordisk Investigational SiteEvanstonIllinois60201-
Novo Nordisk Investigational SiteOxon HillMaryland20745-
Novo Nordisk Investigational SiteBerlinNew Jersey08009-
Novo Nordisk Investigational SiteAlbuquerqueNew Mexico87102-
Novo Nordisk Investigational SiteGreensboroNorth Carolina27408-
Novo Nordisk Investigational SiteCincinnatiOhio45227-
Novo Nordisk Investigational SiteTulsaOklahoma74136-
Novo Nordisk Investigational SiteEugeneOregon97404-
Novo Nordisk Investigational SiteKnoxvilleTennessee37920-
Novo Nordisk Investigational SiteCorpus ChristiTexas78404-
Novo Nordisk Investigational SiteHoustonTexas77074-
Novo Nordisk Investigational SiteManassasVirginia20110-

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